| Device Type ID | 5083 |
| Device Name | Lamp, Infrared, Therapeutic Heating |
| Regulation Description | Infrared Lamp. |
| Regulation Medical Specialty | Physical Medicine |
| Review Panel | Physical Medicine |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Physical Medicine And Rehabilitation Devices Branch (PMDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 890.5500 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | ILY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 5083 |
| Device | Lamp, Infrared, Therapeutic Heating |
| Product Code | ILY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Infrared Lamp. |
| CFR Regulation Number | 890.5500 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
APPLIED BIOPHOTONICS LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ASPEN LASER SYSTEMS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIOPHOTAS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CRYSTAL MEDTECH, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CURAE'LASE INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FUTURE DEVICE AND TECHNOLOGY, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HARBIN QUANKE MEDI-TECHNICAL DEVELOPMENT CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HOME SKINOVATIONS LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
JEISYS MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LED INTELLECTUAL PROPERTIES LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LED INTELLECTUAL PROPERTIES, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LIVETEC GMBH | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
NEUROLUMEN, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PHOENIX THERA-LASE SYSTEMS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
POWERMEDIC APS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PRO MEDICAL SUPPLIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
REIMERS AND JANSSEN GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TEXAS APPLIED BIOMEDICAL SERVICES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
USA LASER BIOTECH IN | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
VARAYA PHOTOCEUTICALS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WELLQUEST INTERNATIONAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WELLRAY MEDICAL LASER, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WS FAR IR MEDICAL TECHNOLOGY CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ZIMMER MEDIZINSYSTEMS GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Insufficient Information | 2 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 3 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | LED Technologies, LLC | II | Apr-28-2016 |
| 2 | Pivotal Health Solutions | II | Mar-06-2015 |